from the now-go-forth-and-innovate dept

Back in 2013, the Supreme Court struck down patents that Myriad Genetics had obtained on naturally-occuring DNA sequences linked to breast cancer. As a result of that judgment, other companies started offering diagnostic tests based on the genes in question. Myriad claimed that despite losing patents on the DNA, its patents on tests based on that DNA were still valid, and took legal action to stop others from offering similar services. As we reported earlier this year, a federal district court judge refused to grant Myriad a preliminary injunction against one of those new entrants, and now the genetic testing patents have been ruled invalid, as Bloomberg reports:

Myriad Genetics Inc. (MYGN) can't block competitors' DNA tests to determine risk for breast and ovarian cancer after a U.S. appeals court said three patents on the tests never should have been issued.

The patents cover products of nature and ideas that aren't eligible for legal protection, the U.S. Court of Appeals for the Federal Circuit said in an opinion posted today on the court's docket. The court upheld a trial judge's decision to allow the competing tests, including those made by Ambry Genetics Corp., to remain on the market.

That's great news for women who can now choose freely from among a range of diagnostic options, often at prices substantially less than comparable testing offered by Myriad. It means that Myriad's monopoly on data derived from those tests has been broken: thanks to its patents, it has created the world's largest database of mutations in breast cancer genes. Most importantly, perhaps, it opens up the field of gene-based diagnostic testing to allow new entrants to experiment and innovate more freely. That, rather than granting monopolies to a few companies, is far more likely to lead to new medical breakthroughs, products and services.

from the sucks-to-be-DownUnder dept

Last year, the Supreme Court made an important ruling in the Myriad Genetics case, effectively saying that genes aren't patentable, even if you can separate them out from the rest of a strand of DNA. Myriad Genetics had isolated two key genes related to breast cancer, BRCA1 and BRCA2 and argued that only it could test for those genes, because of its patent. The Supreme Court soundly rejected that, noting that you cannot patent something in nature, and clearly Myriad did not "make" the genes. Unfortunately, as we'd noted just a few months earlier, a court in Australia had come to the opposite conclusion, saying that Myriad Genetics had legitimate patents on BRCA1 and BRCA2. That case was appealed, and there was some hope that after the US's ruling, higher courts in Australia might see the light. Not yet apparently. An appeals court has agreed that genes are patentable Down Under, which means that such important genetic tests there are likely to be much more expensive and limited.

You can read the full ruling here if you'd like. The case can still be appealed to the Australian High Court, so perhaps it will take the same trajectory as in the US, where it needed the Supreme Court to finally point out the absolute insanity of patenting genes. Though, frankly, if Australia does keeps genes patentable, it might make for an interesting natural experiment to see how much innovation and research happens in both places -- one with, and one without, patents.

from the battling-cancer dept

In June last year we reported on a major ruling from the Supreme Court, which effectively said that you can't patent genes. That ripped a huge hole in Myriad Genetics' monopoly on testing for the BRCA1 and BRCA2 genes that are linked to breast cancer, but that didn't stop it suing some of the new entrants to this market. In particular, it asked a federal judge in Utah to order one of them, Ambry Genetics, to stop providing its gene testing service for those genes. The American Civil Liberties Union filed an amicus brief opposing Myriad's motion, together with a number of other organizations. Here's the latest development in the case:

Yesterday, a federal district court judge in Utah rejected Myriad's motion. Judge Shelby found that Myriad had failed to establish that it was likely to win its lawsuit against Ambry, because there are substantial questions about whether Myriad's patent claims improperly monopolize products of nature, laws of nature, and abstract ideas.

While Myriad's lawsuits can proceed -- for now -- patients continue to have the right to choose other BRCA genetic testing providers. They can obtain a second opinion before making life-changing medical decisions. And they can decide which laboratory will have their data.

That last point is important. As the ACLU explains:

Myriad has used its patents over the genes to create the largest database in the world about BRCA genetic mutations and their medical significance and refuses to share that information with the scientific community.

That underlines another huge problem with gene patents: they allow monopoly-holders to lock up key medical information that could have been used by researchers around the world to advance knowledge and come up with new treatments. Far from accelerating innovation, as apologists for patents like to claim, they throw huge roadblocks in its way. It's yet another reason why the Supreme Court's decision to strike down gene patents should be celebrated.

from the chutzpah dept

Remember how, just a month ago, the Supreme Court had struck down gene patents in the Myriad case? If you don't recall, Myriad claimed, effectively, to have patented the isolated BRCA1 and BRCA2 genes, which are indicators of a likelihood for developing breast cancer. As such, they blocked anyone else from doing tests to find those two genes, and charged a whopping $4,000 or so for anyone who wanted the test. The Supreme Court, thankfully, tossed out those claims, noting that Myriad "did not create or alter any of the genetic information" in those genes, and that if found valid, it would "give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes." That's obviously crazy, so it was good that the Supreme Court rejected those claims.

Immediately after that, a few competitors jumped into the space, offering BRCA1 and BRCA2 testing -- for significantly lower prices. And, Myriad wasted very little time in suing them all for patent infringement. Huh? The short version is that Myriad claims that the Supreme Court merely removed five total claims out of its patents, and it still has 515 remaining claims across 24 patents -- and these tests violate those:

As of the morning of June 13, 2013, Plaintiffs collectively had 24 patents containing 520
claims concerning two genes (BRCA1 and BRCA2), and methods of use and synthetic
compositions of matter related thereto. On June 13, the Supreme Court of the United States
ruled that five patent claims covering isolated naturally occurring DNA were not patent-eligible,
thereby reducing the overall patent estate to 24 patents and 515 patent claims. This case involves
none of those five rejected claims.

The filing goes on to suggest that the Supreme Court ruling really didn't mean very much at all. In many ways, this really does appear to be Myriad giving the middle finger to the Supreme Court. As Tim Lee notes, if Myriad's interpretation of the Supreme Court ruling is correct, then the Court's ruling is effectively meaningless, because Myriad (and anyone else) can effectively write patents for genes by just changing how they structure the patents:

The patent claims the Supreme Court invalidated last month were “composition of matter” claims, covering the chemical structure of the BRCA genes. But Myriad’s patents also have “method” claims covering processes for diagnosing breast cancer. And while these patents use different language than the composition-of-matter patents the high court invalidated, their practical effect on the genetic testing market could be very similar.

Consider Patent 6,951,721, one of the patents cited by Myriad in its lawsuit against competitor Ambry Genetics. It claims the concept of diagnosing breast cancer by “determining the nucleotide sequence of the BRCA1 gene” from a “female individual” and then checking for mutations at specific points on the gene. The patent isn’t limited to any particular technology for isolating or sequencing the patient’s BRCA1 gene. So while it’s not technically a patent on the BRCA1 gene, it might as well be.

Of course, as you look over the details, it seems like Myriad is still going to be in trouble. Effectively, the claims it's relying on may appear to be more similar to a patent on the diagnostic process itself. But, that's a problem for Myriad, because in the big Prometheus Labs case, which the Supreme Court decided a year ago, and which it relied on in the Myriad case itself, medical diagnostics aren't patentable either.

It seems like Myriad is just trying to squeeze some more money out of these patents before it gets smacked down again. Of course, not everyone agrees. Dennis Crouch seems to think they have a "very strong case," while PubPat's outspoken Dan Ravicher feels otherwise:

PubPat director Dan Ravicher, e-mailing Ars from Beijing, described Myriad's new suits as a way to save face with Wall Street. He said the Supreme Court decision was a "total loss" for Myriad, and the synthetic cDNA they are focused on now is not needed for genetic testing. "I am confident they will lose these cases, too, so long as the defendants have the financial resources and institutional desire to fight," said Ravicher.

Of course, it's that last bit that's the challenge. Any such case will take years and millions of dollars. And, during that time some may just choose to settle, and if lower courts side with Myriad and issue injunctions it can be a big risk for the competitors in the space. The end result may work in Myriad's favor even if these cases are completely bogus: it's likely to scare away competitors, and keep the prices of its breast cancer gene tests very high, making it much more likely people will die. I do wonder how Myriad's execs look at themselves in the mirror. There is no reason for doing what they're doing other than to enrich themselves, while ensuring that more women will die from undetected breast cancer. Sickening.

While the FTC has claimed that it's going to go after patent trolls, this seems like another situation where they, along with the DOJ, should also look into Myriad. While it may not be a traditional "troll," there's certainly a strong argument to be made that the company is abusing patents in a manner this is likely to lead to much higher prices for consumers, especially following the Supreme Court rejecting the very premise that they're now relying on in these new lawsuits -- that no one but Myriad can offer tests for BRCA1 and BRCA2. One hopes that the FTC decides to expand its "investigations" into companies like Myriad.

from the chop-off-a-finger-and-patent-it dept

Well, this is unfortunate. We were quite happy with US district court judge Robert Sweet last year for making it clear that isolated genes are not patentable material in the Myriad Genetics case. This was one of those annoying patent situations where so many people had just assumed that genes were patentable for decades, without a single court testing that theory out. So industries were built up around the idea that genes could be patented. Thankfully, Sweet didn't let that bother him in pointing out that gene patents "are directed to a law of nature and were therefore improperly granted."

Of course, as expected, Myriad appealed, and even the Justice Department weighed in, saying genes shouldn't be patentable. However, the results of the appeal are in... and the Federal Circuit appeals court (CAFC) has reversed the lower court and said that patenting genes is just fine. The reasoning is bordering on ridiculous. The court effectively states that because isolated genes are isolated rather than a part of the full DNA strand, they are not "found in nature."

It is undisputed that Myriad’s claimed isolated DNAs exist in a distinctive chemical form--as distinctive chemical molecules--from DNAs in the human body, i.e., native DNA. Native DNA exists in the body as one of forty-six large, contiguous DNA molecules. Each DNA molecule is itself an integral part of a larger structural complex, a chromosome. In each chromosome, the DNA molecule is packaged around histone proteins into a structure called chromatin, which in turn is packaged into the chromosomal structure....

Isolated DNA, in contrast, is a free-standing portion of a native DNA molecule, frequently a single gene. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule.

Later, it reiterates that separating out these genes make them somehow "different" and not a part of nature:

In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.

Basically, they seem to be arguing that because a severed finger is not attached to a hand, the finger is not naturally occurring, and, thus, is patentable. Think about that. The dissenting judge in this ruling used a slightly less gruesome analogy, saying that the majority was basically saying that while a tree occurs in nature, snapping a leaf off the tree makes that leaf patentable.

The one good thing about the ruling is that it still rejects parts of Myriad's patents, but for other reasons, not because they're unpatentable parts of nature. The dissenting opinion from Judge Bryson (starting on page 88 of the ruling) is well worth reading. It starts out by attacking the problem with common sense, saying that if you were to ask someone if genes should be patented, they would answer, "Of course not. Patents are for inventions. A human gene is not an invention." But then Bryson goes on to discuss the more specific points raised by Myriad. First, he points out that Myriad didn't even really "invent" the key parts here:

At the outset, it is important to identify the inventive contribution underlying Myriad’s patents. Myriad was not the first to map a BRCA gene to its chromosomal location. That discovery was made by a team of researchers led by Dr. Mary-Claire King.... And Myriad did not invent a new method of nucleotide sequencing. Instead, it applied known sequencing techniques to identify the nucleotide order of the BRCA genes. Myriad’s discovery of those sequences entailed difficult work, and the identified sequences have had important applications in the fight against breast cancer. But the discovery of the sequences is an unprotectable fact, just like Dr. King’s discovery of the chromosomal location of the BRCA1 gene.

From there, Judge Bryson points out that an isolated gene clearly is a part of nature, and thus unpatentable:

Myriad is claiming the genes themselves, which appear in nature on the chromosomes of living human beings. The only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes from the environment in which they are found in nature. While the process of extraction is no doubt difficult, and may itself be patentable, the isolated genes are not materially different from the native genes. In this respect, the genes are analogous to the “new mineral discovered in the earth,” or the “new plant found in the wild” that the Supreme Court referred to in Chakrabarty. It may be very difficult to extract the newly found mineral or to find, extract, and propagate the newly discovered plant. But that does not make those naturally occurring items the products of invention.

The same is true for human genes.

This case is far from over. It seems likely that CAFC will quickly be asked to rehear the case en banc (with the full slate of judges in the court, rather than just a panel of three), and after that it will likely go to the Supreme Court. Still, it's unfortunate that CAFC went this way, and hopefully a later ruling rejects this momentary lapse of reason.

In the meantime, it'll be important to pay close attention to what happens in the "sister" case to this one, Prometheus Laboratories v. Mayo Collaborative Services, in which there's a question of whether or not diagnostic tests can be patentable. In that case, like this one, CAFC said diagnostic tests are patentable, and that case has now moved on to the Supreme Court, which will likely hear the case in the fall. That may be a precursor to the final result in this case.

from the and-we-wait dept

It's been just over a year since a district court judge surprised much of the world by saying that you could not patent genes. This was a huge, and very smart ruling, but it certainly upset those who had been patenting genes (or making money off of those patenting genes) for many years. They insisted that this simply couldn't be true at all, and tried to hide behind claims that they weren't really patenting genes at all, but merely the process to separate out the genes. To hear them talk about it, the judge's initial ruling was so far out of left field that the appeals court couldn't possibly uphold it. Well, we'll soon find out. The case against Myriad Genetics and its patenting of the BRCA1 and BRCA2 genes has finally been heard by the Appeals Court, and we're waiting to see if they recognize the absurdity of patenting genes... or if they figure out some way to twist the law (which only allows patents on things made by humans...) into keeping gene patents around. Of course, whoever wins, this case will be appealed to the Supreme Court, who very well may want to weigh in. What's really sad is that a big part of the argument by those who want the lower court ruling overturned is that it will "upset" an entire industry. The real problem, of course, is that an entire industry was built up around these highly questionable patents in the first place.

Myriad is appealing on two points. First, it's claiming that the people who sued have no standing, because there's no controversy since the company hadn't taken any action against the plaintiffs. That seems like a pretty weak argument, given that Myriad had made it clear that it would enforce its patents against anyone else who tried to do research or genetic testing on the specific BRCA1/2 genes. Second, Myriad is claiming that the patents are valid, because it connected not just the gene (which is unpatentable), but the isolated gene combined with the information that this mutation predicts breat and ovarian cancer (also, unpatentable by itself). Basically, Myriad is suggesting that tying two unpatentable things together make this patentable. That makes little sense, and hopefully the appeals court sees through it as quickly as the district court did.